The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent infusion and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of IV mechanical complications requiring IV replacement.

The Orchid SRVTM is for use with patients two (2) weeks of age and older.

Device Description

The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window, automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.

AI/ML Overview

The document provided is a 510(k) summary for the Orchid Safety Release Valve™ (K241415), which is being submitted for substantial equivalence to a previously cleared device (K232094). The primary difference between the two devices lies in a change to the contraindications, allowing for use with blood, which required additional hemocompatibility testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in numerical terms for the hemocompatibility testing. Instead, it states that "additional testing performed to support limited blood contact did not raise new questions for safety or effectiveness." This implies that the device met internal acceptance criteria for these tests.

However, the "Table 1: General Technological Characteristics Comparison" provides a comparison of features, and for "Contraindications," it implicitly describes the change and how it was supported:

Acceptance Criteria (Implied)	Reported Device Performance
Device is safe for use with blood, blood products, or biologics.	Contraindications have been updated to remove "blood, blood products, or" from the contraindication statements. Blood and blood product use is supported by additional hemocompatibility testing performed on the subject device (refer to Section X below). This testing did not raise new questions for safety or effectiveness.
Hemocompatibility (e.g., PTT, Complement Activation, PLC, Hemolysis)	Results from Partial Thromboplastin Time (PTT), Complement Activation, Platelet and Leukocyte Count (PLC) assay, and mechanical hemolysis tests conducted per ISO 10993-4: 2017 were acceptable, demonstrating the device's safe use with blood products.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the hemocompatibility tests or the provenance of the data (e.g., in vitro, animal, human). It only states that these tests were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The hemocompatibility tests are typically laboratory-based and follow established international standards (ISO 10993-4: 2017), which define parameters for assessing blood interactions, rather than relying on expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies with human assessors, not for bench or laboratory testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not done. This device is a mechanical medical device, not an AI or imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable and not provided. The device is a mechanical safety release valve, not an algorithm, so there is no "standalone" algorithm performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the hemocompatibility testing, the ground truth is established by the accepted scientific principles and thresholds defined within the ISO 10993-4: 2017 standard for biological evaluation of medical devices. The test results are compared against these established criteria to determine safety.

8. The sample size for the training set

This information is not applicable and not provided. The device is a mechanical product, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 6, 2024

Linear Health Sciences LLC Jessica Czamanski Director of Product and Regulatory Affairs 840 Research Parkway Ste 250 Oklahoma City, Oklahoma 73104

Re: K241415

Trade/Device Name: Orchid Safety Release Valve™ Regulation Number: 21 CFR 880.5220 Regulation Name: Intravenous Catheter Force-Activated Separation Device Regulatory Class: Class II Product Code: QOI Dated: August 9, 2024 Received: August 9, 2024

Dear Jessica Czamanski:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors

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OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241415

Device Name Orchid Safety Release Valve™

Indications for Use (Describe)

The Orchid SRV™ is intended to aid in reduction of IV mechanical complications requiring IV replacement.

The Orchid SRVTM is for use with patients two (2) weeks of age and older.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over The Counter Use (21 CFR 801 Subpart C)

| X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image is a logo for Linear Health Sciences. The word "LINEAR" is in blue, with a small trademark symbol in the upper right corner. Below that, the words "HEALTH SCIENCES" are in gray.

K241415 - 510(k) SUMMARY

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92.

Submitter l.

Submitter's Name:	Linear Health Sciences, LLC
Contact Person:	Mr. Daniel ClarkCEO
Address:	840 Research Parkway, STE 250Oklahoma City, OK 73104
Telephone:	(310) 721-6222
Email:	dan.clark@linearsciences.com
Date Preparation:	September 6, 2024

II. Application Correspondent

Contact's Name:	Linear Health Sciences, LLC
Contact Person:	Jessica CzamanskiDirector of Product and Regulatory Affairs
Address:	840 Research Parkway, STE 250Oklahoma City, OK 73104
Telephone:	(754) 422-9101
Email:	jessica.czamanski@linearsciences.com

III. Device

Trade Name:	Orchid Safety Release Valve™
Common Name:	Quick Disconnect Accessory
Classification Name:	Intravenous Catheter Force-Activated Separation Device
Product Classification:	Class II
Regulation Number:	21 CFR § 880.5220
Product Code:	QOI

IV. Predicate Device

Manufacturer:	Linear Health Sciences, LLC
Device Name:	Orchid Safety Release ValveTM

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Image /page/5/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large blue font, with the "I" stylized as a vertical line with two small squares on either side. Below "LINEAR" in a smaller, light gray font are the words "HEALTH SCIENCES". The TM symbol is in the upper right corner of the word "LINEAR".

510(k) Number:	K232094
Product Classification:	Class II
Regulation Number:	21 CFR § 880.5220

V. Device Description

VI. Intended Use

The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory, provided sterile and for single use, in line with an IV administration set and IV extension set on a patient. The Orchid SRV™ provides a quick separation feature that allows the device to quickly separate into two halves upon tension, closing the flow path to prevent leakage. The device is intended to reduce the risk of IV catheter failure, requiring IV catheter replacement.

VII. Indications for Use

The Orchid SRV™ is intended to aid in reduction of IV mechanical complications requiring IV replacement. The Orchid SRV™ is for use with patients two (2) weeks of age and older.

VIII. Comparison of Technological Characteristics with the Predicate Devices

There are no differences in technological characteristics of the device. Only differences are present in the labeling of the Orchid Safety Release Valve, specifically the contraindications to allow for use with blood.

The following table (Table 1) provides an overview of general technological characteristics in comparison to the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is written in a large, blue, sans-serif font. The letters are spaced closely together, and the "I" in "LINEAR" is stylized to look like two vertical lines. The letters "TM" are written in a small, superscript font in the upper right corner of the word "LINEAR". Below the word "LINEAR", the words "HEALTH SCIENCES" are written in a smaller, gray, sans-serif font.

Table 1: General Technological Characteristics Comparison
Product Features	ProposedLinear Health Sciences'Orchid Safety ReleaseValve™(K241415)	PredicateLinear Health Sciences'Orchid Safety ReleaseValve™(K232094)	SubstantialEquivalenceDetermination
Classification	Class II	Class II	Same
Product Code	QOI	QOI	Same
RegulationNumber	§880.5220	§880.5220	Same
DeviceClassificationName	Intravenous CatheterForce-ActivatedSeparation Device	Intravenous CatheterForce-ActivatedSeparation Device	Same
Intended Use	The Linear HealthSciences™ Orchid SafetyRelease Valve™ is atension-activatedaccessory, providedsterile and for single use,in line with an IVadministration set and IVextension set on a patient.The Orchid SRV™provides a quickseparation feature thatallows the device toquickly separate into twohalves upon tension,closing the flow path toprevent leakage. Thedevice is intended toreduce the risk of IVcatheter failure, requiringIV catheter replacement.	The Linear HealthSciences™ Orchid SafetyRelease Valve™ is atension-activatedaccessory, providedsterile and for single use,in line with an IVadministration set and IVextension set on apatient. The OrchidSRV™ provides a quickseparation feature thatallows the device toquickly separate into twohalves upon tension,closing the flow path toprevent leakage. Thedevice is intended toreduce the risk of IVcatheter failure, requiringIV catheter replacement.	Same
Indications for Use	The Linear HealthSciences™ Orchid SafetyRelease Valve™ is atension-activatedaccessory for singlepatient use and placedbetween the existing IVadministration set and IVextension set connection.The Orchid SRV™ isintended for use withelectronic IV pumps in IVcatheter applicationswhere tension may act onthe IV tubing. The OrchidSRV™ is designed toallow flow to an IVcatheter. When excessivetension acts on the line,the Orchid SRV™separates and closes the	The Linear HealthSciences™ Orchid SafetyRelease Valve™ is atension-activatedaccessory for singlepatient use and placedbetween the existing IVadministration set and IVextension set connection.The Orchid SRV™ isintended for use withelectronic IV pumps in IVcatheter applicationswhere tension may act onthe IV tubing. The OrchidSRV™ is designed toallow flow to an IVcatheter. When excessivetension acts on the line,the Orchid SRV™separates and closes the	Same
Table 1: General Technological Characteristics Comparison
Product Features	ProposedLinear Health Sciences'Orchid Safety ReleaseValveTM(K241415)	PredicateLinear Health Sciences'Orchid Safety ReleaseValveTM(K232094)	SubstantialEquivalenceDetermination
Contraindications	flow path in bothdirections. The OrchidSRVTM can be usedduring intermittentinfusion and continuousinfusion.The Orchid SRVTM isintended to aid inreduction of IVmechanical complicationsrequiring IV replacement.The Orchid SRVTM is foruse with patients two (2)weeks of age and older.The Orchid SRVTM shouldnot be used for any typeof fluid administrationother than intravenous.Not for use with feedingtubes, drains, or othertubing applicationsoutside of intravenousapplications. Not for usein withdrawing blood orfluids. Not for intra-arterialuse. Not for use withpower injection systemsor high-pressure infusionsystems. Not for use withumbilical vessel catheters.Not for use under 2 weeksof age. Not for use in lineduring the transfusion ofbiologics.	flow path in bothdirections. The OrchidSRVTM can be usedduring intermittentinfusion and continuousinfusion.The Orchid SRVTM isintended to aid inreduction of IVmechanical complicationsrequiring IV replacement.The Orchid SRVTM is foruse with patients two (2)weeks of age and older.The Orchid SRVTM shouldnot be used for any typeof fluid administrationother than intravenous.Not for use with feedingtubes, drains, or othertubing applicationsoutside of intravenousapplications. Not for usein withdrawing blood orfluids. Not for intra-arterialuse. Not for use withpower injection systemsor high-pressure infusionsystems. Not for use withumbilical vesselcatheters. Not for useunder 2 weeks of age.Not for use in line duringthe transfusion of blood,blood products, orbiologics.	Contraindications havebeen updated toremove "blood, bloodproducts, or" from thecontraindicationstatements. Blood andblood product use issupported byadditionalhemocompatibilitytesting performed onthe subject device(refer to Section Xbelow).
Materials	Polycarbonate andsilicone	Polycarbonate andsilicone	Same
Environment ofUse	Hospital	Hospital	Same
Provided Sterile	Yes	Yes	Same
Principle ofOperation	The Orchid SafetyRelease ValveTM has luerlock connections that willlock the device in placeduring use. The femaleluer connects to anadministration set while	The Orchid SafetyRelease ValveTM has luerlock connections that willlock the device in placeduring use. The femaleluer connects to anadministration set while	Same
Table 1: General Technological Characteristics Comparison
Product Features	ProposedLinear Health Sciences'Orchid Safety ReleaseValveTM(K241415)	PredicateLinear Health Sciences'Orchid Safety ReleaseValveTM(K232094)	SubstantialEquivalenceDetermination
	the male luer connects toa vascular access devicehub or extension set.Once connected thedevice allows forcontinuous flow. TheOrchid SRV will separateinto the male and femalesubassemblies, upon atension event,automatically closing theflow path, whilemaintaining sterility andpreventing fluid leakageform the device.	the male luer connects toa vascular access devicehub or extension set.Once connected thedevice allows forcontinuous flow. TheOrchid SRV will separateinto the male and femalesubassemblies, upon atension event,automatically closing theflow path, whilemaintaining sterility andpreventing fluid leakageform the device.
User Profile	Physician or clinicalpersonnel with clearanceto administer IV sets andrelated products	Physician or clinicalpersonnel with clearanceto administer IV sets andrelated products	Same
Separation Force	1-4.2 lbf	1-4.2 lbf	Same
Vascular AccessCatheter Type	Peripheral and Central IVCatheters	Peripheral and Central IVCatheters	Same
For Use withElectronic Pumps	Yes	Yes	Same
Single Use	Yes	Yes	Same
Continuous andIntermittentInfusion	Yes	Yes	Same
Sterilization	Ethylene Oxide	Ethylene Oxide	Same
SAL	10-6	10-6	Same
Shelf-Life	2 years	2 years	Same

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ﮧ :

IX. Sterilization

There are no differences in the sterilization process between the subject and the predicate device.

X. Performance Data

The following performance data was considered in support of the substantial equivalence determination.

Performance Testing - Bench

There is no change in performance data since there are no changes to the device or its manufacturing processes.

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Image /page/9/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in blue, with a small "TM" symbol in the upper right corner. Below "LINEAR" is the phrase "HEALTH SCIENCES" in gray. The logo is simple and modern, with a focus on the company's name.

Biocompatibility

To demonstrate the device's safe use with blood products, the following additional hemocompatibility tests were conducted per ISO 10993-4: 2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood: Partial Thromboplastin Time (PTT), Complement Activation, Platelet and Leukocyte Count (PLC) assay, and mechanical hemolysis.

Electrical Safety and Electromagnetic Compatibility (EMC)

There are no electrical or metal components in the proposed Orchid Safety Release Valve™; therefore, the proposed device does not require EMC and Electrical Safety evaluation. Justification of the latter has been included in this submission to support the MR Safe symbol to the device labeling.

Software Verification and Validation Testing

The Orchid Safety Release Valve™ does not contain software; therefore, the proposed device does not require software verification and validation testing.

Performance Testing - Animal

This submission does not include any animal performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.

XI. Conclusion

The Orchid Safety Release Valve™ has the same intended use, environment, operating principle and fundamental technology, manufacturing, and materials as the predicate device. Additional testing performed to support limited blood contact did not raise new questions for safety or effectiveness. The information provided in this submission demonstrates that the subject device, Orchid Safety Release Valve™ is substantially equivalent to its predicate, Orchid Safety Release Valve™ cleared under K232094.

Regulation Number and Section

§ 880.5220 Intravenous catheter force-activated separation device.

(a)
Identification. An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Separation force testing;
(ii) Validation of anti-reconnect features;
(iii) Air and liquid leakage testing, both before and after separation;
(iv) Luer connection testing;
(v) Flow rate testing;
(vi) Particulate testing; and
(vii) Microbial ingress testing.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate that the device is sterile and non-pyrogenic.
(5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(6) Device labeling must include:
(i) Instructions for use; and
(ii) A discussion of catheter dressings intended to be used with the device.